Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Psychological Stress; Cardiovascular

Treatments: Behavioral: Trier Psychological Stressor; Other: Placebo antioxidant concentrate; Dietary Supplement: High Antioxidant Spice Blend

Study type: Interventional

Funder types: Other

Identifiers

NCT00954902

G264

Details and patient eligibility

About

The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.

Enrollment: 32 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 30-65
• BMI 25-40
• Non tobacco user
• Resting BP < 160/100
• Fasting Glucose < 126 mg/dL

Exclusion criteria

• Tobacco use
• Use of female hormones
• Breastfeeding or planning to become pregnant during the study
• Use of lipid-lowering or blood pressure medications
• Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication
• Chronic use of any form of anti-inflammatory or anti-psychotic drugs
• Use of daily aspirin or supplements (except stable dose of calcium)
• History of heart attack or stroke, renal or hepatic disease, implanted medical devices, gastrointestinal disease
• Allergy or intolerance to any study foods
• Injury to fingers or arms that would interfere with vascular and blood pressure measurements
• Inability to comply with study protocol
• Allergy to adhesives or latex
• Aerobic exercise exceeding 2 hours per week

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

32 participants in 4 patient groups

No spice, no stress

Sham Comparator group

Description:

Subject are given placebo capsules and told they contain an antioxidant concentrate

Treatment:

Other: Placebo antioxidant concentrate

No Spice, Stress

Sham Comparator group

Description:

Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.

Treatment:

Behavioral: Trier Psychological Stressor

Other: Placebo antioxidant concentrate

Spice, no stress

Experimental group

Treatment:

Dietary Supplement: High Antioxidant Spice Blend

Spice and Stress

Experimental group

Treatment:

Behavioral: Trier Psychological Stressor

Dietary Supplement: High Antioxidant Spice Blend